DDrare: Database of Drug Development for Rare Diseases

Searched query = "Idiopathic interstitial pneumonia", "IIPs", "Idiopathic pulmonary fibrosis", "IPF", "Usual interstitial pneumonia", "UIP", "Non-specific interstitial pneumonia", "NSIP", "Acute interstitial pneumonia", "AIP", "Diffuse alveolar damage", "DAD", "COP", "Organizing pneumonia", "OP", "Desquamative interstitial pneumonia", "DIP", "Respiratory bronchiolitis - associated interstitial lung disease", "RB-ILD", "Lymphocytic interstitial pneumonia", "LIP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = (18)F-FDG; 18F-FDG; 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt; 534-1508; 68Ga-BMV101; ACETYLCYSTEINE; ACT-064992; ACT-064992 (macitentan); ART-123; AZAPRED; Acetate; Acetylcysteine; Acetylcysteine Effervescent Tablets; Adult human mesenchymal stem cells; Aerosol interferon-gamma; Air; Alemtuzumab; Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs); Ambrisentan; Antimicrobial therapy: Co-trimoxazole or Doxycycline; Atezolizumab; Autoantibody Reductive Therapy; Autologous Adipose Derived MSCs (ADMSCs); Autologous Stromal Vascular Fraction (SVF); Autologous mesenchymal stem cells derived from bone marrow; Aviptadil; Aviptadil, 66 microgram/mL; Azathioprine; Azathioprine/prednisone; Azithromycin; BBT-877, Multiple doses; BBT-877, Single dose; BG00011; BI 1015550; BIBF 1120; BIBF 1120 ES; BIBF1120; BLD-2660; BMS-986020; BMS-986278; BOSENTAN; Bardoxolone; Bardoxolone methyl; Beclometasone dipropionate; Bevacizumab; Blood sample collection; Bone marrow mesenchymal stem cells; Bosentan; C21; CBDCA; CC; CC-90001; CC-930; CD3/CD19 negative hematopoietic stem cells; CNC; CNTO 888 1 mg/kg; CNTO 888 15 mg/kg; CNTO 888 5 mg/kg; CNTO888; CO; CO-TRIMOXAZOLE; COMPOUND 21; Carbon; Carbon monoxide; Carboplatin; Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03); Co-trimoxazole; Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids; Corticosteroid (prednisolone); Cotrimoxazole; Cravit; Cromoglicate; Cromoglicato disodico; Cromoglycate; Cromolyn; Cromolyn Sodium; Cromolyn sodio (cromoglicato disodico, DSCG); Cromolyn sodium [Disodium Cromoglycate]; Cyclophosphamide; Cyclosphamine; Cysteine; DEX284; DPA; Dabigatran; Dasatinib; Dasatinib + Quercetin; Device: Auto-titrating oxygen system; Device: Centricyte 1000; Device: MRI; Device: Oxymizer® compared to CNC; Dextromethorphan; Diagnostic Test: Metabolomics; Diagnostic Test: PET Imaging; Disodium Cromoglycate [cromolyn sodium]; Disodium cromoglycate (DSCG); Doxycycline; EGCG; ENDOXAN; ESBRIET; EZ-2053; EZ-2053 5mg/kg; Endobronchial infusion of adult mesenchymal stem cells; Endoxan; Epigallocatechin; Epigallocatechin-3-gallate (EGCG); Erivedge; Esbriet; Esbriet® (Pirfenidon); Etanercept; Etoposide; FG-3019; FG-3019 10mg/mL in 10 mL vials; FLUORINE (18F) FLUDEOXYGLUCOSE; Fludarabine; Fludeoxyglucose; Fluimucil; Fluimucil® 600 mg effervescent tablets; Formoterol; Formoterol fumarate dihydrate; Fostair; G-CSF; G321605; G451990; GBT440; GBT440 300 mg capsule; GBT440 300 mg tablet; GC1008; GKT137831; GLPG1205; GLPG1690; GLPG1690 600 mg QD; GS-6624; GSK2126458; GSK3008348; GSK3008348 Nebuliser solution; Gallium68-Dota-Noc; Gefapixant; Granulocyte Colony Stimulating Factor; HEC 68498; HEC585; High dose BIBF 1120 twice daily; Humanized anti-alpha v beta 6 mAb; Hydroxyurea; Hyperoxia; Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment; Hyperpolarized 129-Xenon gas; IDL-2965 Oral Capsule; INO; INOmax; INOmax 400ppm mol/mol inhalation gas; IW001; Ifenprodil; Iloprost; Iloprost Inhalation Solution (Ventavis); Imatinib; Imatinib Mesylate (Gleevec); Immukin; Inhaled Nitric Oxide; Inhaled Nitric Oxide - 30 mcg/kg IBW/hr; Inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr; Inhaled TD139; Inhaled carbon monoxide; Inhaled nitric oxide 75 mcg/kg IBW/hr; Inomax; Interferon Gamma; Interferon alpha oral lozenge; Interferon gamma-1b; Interferon gamma-1b (Actimmune); Interferon-alpha lozenges; Interferon-gamma 1b; Intermediate dose BIBF 1120 twice daily; Jaktinib Dihydrochloride Monohydrate 50mg BID and Mimic tablets of jakitinib hydrochloride 75mg BID and Acetylcysteine Effervescent Tablets; Jaktinib Dihydrochloride Monohydrate 75mg BID and Mimic tablets of jakitinib hydrochloride 50mg BID and Acetylcysteine Effervescent Tablets; Jin-shui Huan-xian granule; KD025; L - Antineoplastic and immunomodulating agents; L01 - Antineoplastic agents; L01X - Other antineoplastic agents; L01XE - Protein kinase inhibitors; L01XE31; L01XE31 - Nintedanib; LANREOTIDE ACETATE; LEBRIKIZUMAB; LPA1; Lanreotide; Lansoprazole; Lebrikizumab; Letairis; Letairis 10 mg; Letairis 5 mg; Liberase Enzyme (Roche); Losartan; Low dose BIBF 1120 twice daily; Low dose BIBF1120 once daily; Lung Spheroid Stem Cells 100 million; Lung Spheroid Stem Cells 200 million; Lung stem cells; MACITENTAN; MESNA; MG-S-2525; MONITOR; Macitentan; Medical air; Medical air (sham O2); Mesna; Minocycline; Montelukast; Morphine; Morphine Sulfate; Morphine hydrochloride; Morphine sulfate; Moxifloxacin; Mycophenolate; Mycophenolate mofetil; N-Acetylcysteine, (NAC); N-acetyl cysteine; N-acetylcysteine; NAC; NALBUPHINE HYDROCHLORIDE; ND-L02-s0201; ND-L02-s0201 for injection; NINTEDANIB; NITRIC OXIDE; Na; Nalbuphine; Nalbuphine ER; Nalbuphine Extended-Realease (ER) Tablets; Nalbuphine Extended-Release (ER) Tablets; Nandrolone; Nandrolone Decanoate; Nandrolone decanoate; Nintedanib; Nitric Oxide; Nivolumab; None; OFEV®; ORIN1001; Octreotide; Ofev; Ofev 100 mg capsule; Ofev 150 mg capsule; Omeprazole; Omeprazole (UK licensed generic product); Other: 60% Oxygen; Other: Control; Other: Cough monitor; Other: Medical air; Other: No Intervention: Standard of Care; Other: Oxygen; Other: Oxygen (2Liter/min); Other: Oxygen (4Liter/min); Other: Pulmonary rehabilitation program; Other: Standard of Care; Other: Untreated Cohort; Oxygen; Oxygen 40 %; PA101; PAMREVLUMAB; PBI4050; PD00377 Na-salt; PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714; PIR, S-7701; PIRFENIDONE; PLN-74809; PLN-74809-000; PREDNISOLONE; PRIVIGEN 100mg/ml; PRM-151; PZN 8881655(RochePharma AG); Paclitaxel; Pamrevlumab; Pirfenidone; Pirfenidone and nintedanib; Pirfenidone or nintedanib; Pirfenidoneone; Placebo; Pomalidomide; Pomalidomide (CC-4047; Prednisolone; Prednisone; Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution; Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF); QAX576; Quercetin; RIXATHON 500 mg; RO0220912; RO0280296; RO5490255; RO5490255/F01-02; RVT-1601; RVT-1601 (formerly, PA101B); Radiation: FDG PET scan; Radiation: GSK26346763: ([18F]-FBA-A20FMDV2) IV infusion; Radiation: Knottin tracer; Remicade; Revatio; Revatio 20 mg; Rituximab; Ro 47-0203; SAR156597; SEPTRIN; SILDENAFIL; SM04646; SODIUM CROMOGLICATE; SULFAMETHOXAZOLE; Salbutamol; Saracatinab; Septrin; Sildenafil; Sildenafil (50 mg); Sildenafil Citrate; Sildenafil and Losartan; Simtuzumab; Sirolimus; Sivelestat; Standard Steroid Treatment; Standard of Care; Sterile Normal Saline for Intravenous Use; Sub-Study: Nintedanib; Sub-Study: Pirfenidone; Sulfamethoxazole; Sulfate; Sulphamethoxazole; Symbicort; TBC; TD-1058; TD139; TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A; TR0311; TRACLEER; TRIMETHOPRIM; TRK-250; Tacrolimus; Tetrandrine; Tetrathiomolybdate; Thalidomide; Thalidomide Pharmion; The Standard Steroid Treatment, Plasma Exchange and rituximab; Thiotepa; Thrombomodulin Alfa; Thrombomodulin alfa; Tiotropium; Tipelukast; Tracleer; Traditional Chinese Medicine Formulation; Tralokinumab; Tralokinumab cohort 1; Tralokinumab cohort 2; Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor; Treatment as Usual (TAU); Treprostinil; Treprostinil sodium for inhalation; Trimethoprim; UROMITEXAN; Uromitexan; VAY736; VISMODEGIB; VOLIBRIS; VRP700; Valganciclovir; Vasoactive intestinal peptide; Vismodegib; Volibris; Warfarin; Xenon; ZL-2102; ZSP1603 12.5 mg; ZSP1603 25 mg; ZSP1603 50 mg; ZSP1603 7.5 mg; Zileuton; Ziritaxestat; [18F]-FBA-A20FMDV2; [18F]FP-R01-MG-F2; [68Ga]CBP8; [BG00011]; [RVT-1601 (in precedenza PA101B)]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2015-002619-14-FR (EUCTR)	21/06/2017	25/04/2018	Efficacy and safety of nintedanib co-administered with sildenafil in IPF patients with advanced lung function impairment	A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment	patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil	Boehringer Ingelheim France	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;Italy;United Kingdom;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
2	EUCTR2015-005131-40-CZ (EUCTR)	20/03/2017	16/12/2016	A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease.	A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION.	Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	176	Phase 2	United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
3	EUCTR2015-005131-40-HU (EUCTR)	16/01/2017	01/12/2016	A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease.	A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION.	Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	176	Phase 2	United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Hungary;Czech Republic;Canada;Belgium;South Africa;Netherlands;Germany
4	NCT02951429 (ClinicalTrials.gov)	December 31, 2016	28/10/2016	Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension	A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients With Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Group 3 Pulmonary Hypertension	Idiopathic Pulmonary Fibrosis	Drug: Pirfenidone;Drug: Placebo;Drug: Sildenafil	Hoffmann-La Roche	NULL	Completed	40 Years	80 Years	All	177	Phase 2	Belgium;Canada;Czechia;Egypt;Germany;Greece;Hungary;Israel;Italy;Netherlands;South Africa;Spain;Turkey;Czech Republic;United Arab Emirates
5	EUCTR2015-005131-40-BE (EUCTR)	16/12/2016	20/10/2016	A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease.	A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION.	Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	176	Phase 2	United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2015-005131-40-DE (EUCTR)	08/12/2016	25/10/2016	A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Addedto Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis andRisk of Pulmonary Hypertension due to the lung disease.	A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLEDSTUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTSWITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION.	Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	176	Phase 2	United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
7	EUCTR2015-005131-40-GR (EUCTR)	06/12/2016	03/11/2016	A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease.	A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION.	Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	176	Phase 2	United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Netherlands;Germany
8	EUCTR2015-005131-40-NL (EUCTR)	02/12/2016	13/10/2016	A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease.	A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION.	Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	176	Phase 2	United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Netherlands;Germany
9	EUCTR2015-005131-40-ES (EUCTR)	20/10/2016	09/09/2016	A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease.	A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION.	Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	176	Phase 2	United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
10	EUCTR2015-002619-14-GB (EUCTR)	01/08/2016	08/09/2016	Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment	INSTAGE(TM): A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM)	patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 19.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]		Boehringer Ingelheim Limited	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2015-002619-14-BE (EUCTR)	25/07/2016	03/06/2016	Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment	INSTAGE (TM) : A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE (TM)	patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil	SCS Boehringer Ingelheim Comm. V	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
12	EUCTR2015-002619-14-DE (EUCTR)	21/07/2016	04/05/2016	Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment	INSTAGE(TM): A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM)	patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
13	NCT02802345 (ClinicalTrials.gov)	June 30, 2016	14/6/2016	Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment	INSTAGE: A 24-week, Double-blind, Randomized, Parallel-group Study Evaluating the Efficacy and Safety of Oral Nintedanib Co-administered With Oral Sildenafil, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Advanced Lung Function Impairment	Idiopathic Pulmonary Fibrosis	Drug: Nintedanib;Drug: Placebo;Drug: Sildenafil	Boehringer Ingelheim	NULL	Completed	40 Years	N/A	All	274	Phase 3	United States;Australia;Belgium;Canada;France;Germany;India;Italy;Japan;Korea, Republic of;Mexico;Spain;United Kingdom
14	EUCTR2015-002619-14-ES (EUCTR)	29/06/2016	17/05/2016	Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment	A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment	patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil	Boehringer Ingelheim España, S.A.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
15	NCT01382368 (ClinicalTrials.gov)	September 2011	2/5/2011	Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients	Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients	Chronic Obstructive Pulmonary Disease;Idiopathic Pulmonary Fibrosis	Drug: Sildenafil	Rabin Medical Center	NULL	Enrolling by invitation	30 Years	90 Years	Both	60	Phase 4	Israel
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	NCT00981747 (ClinicalTrials.gov)	September 2009	19/9/2009	Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis	A Clinical Treatment Trial Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis	Idiopathic Pulmonary Fibrosis;Pulmonary Fibrosis	Drug: Sildenafil;Drug: Losartan;Drug: Sildenafil and Losartan;Drug: Placebo Oral Tablet	Alicia Gerke	Pulmonary Fibrosis Foundation	Terminated	18 Years	99 Years	All	12	Phase 2;Phase 3	United States
17	NCT00517933 (ClinicalTrials.gov)	August 2007	15/8/2007	Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis	Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis	Pulmonary Fibrosis;Hypertension, Pulmonary	Drug: Sildenafil Citrate;Other: Placebo	Duke University	National Heart, Lung, and Blood Institute (NHLBI);Pfizer	Completed	18 Years	N/A	All	180	Phase 3	United States
18	NCT00625079 (ClinicalTrials.gov)	February 2007	19/2/2008	Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil	Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot Study	Pulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis;Interstitial Lung Disease;Pulmonary Hypertension	Drug: sildenafil	University of California, Los Angeles	Pfizer	Withdrawn	N/A	N/A	All	0	Phase 4	United States
19	NCT00359736 (ClinicalTrials.gov)	July 2006	31/7/2006	Sildenafil Study to Treat Idiopathic Pulmonary Fibrosis	Vasodilator Therapy and Exercise Tolerance in IPF Patients	Alveolitis, Fibrosing;Fibrosis, Pulmonary;Hypertension, Pulmonary	Drug: sildenafil	VA Office of Research and Development	NULL	Completed	40 Years	85 Years	All	29	Phase 2	United States
20	NCT00352482 (ClinicalTrials.gov)	November 2004	13/7/2006	Sildenafil to Increase Exercise Capacity in Individuals With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension	Sildenafil Treatment in Patients With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - a Pilot Cross-over Study	Pulmonary Fibrosis;Hypertension, Pulmonary	Drug: Sildenafil (50 mg)	National Heart, Lung, and Blood Institute (NHLBI)	NULL	Completed	19 Years	N/A	Both	20	Phase 2	United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2015-002619-14-FR
(EUCTR)

21/06/2017

25/04/2018

Efficacy and safety of nintedanib co-administered with sildenafil in IPF patients with advanced lung function impairment

A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment

patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Revatio
Product Name: Revatio 20 mg
Product Code: sildenafil
INN or Proposed INN: SILDENAFIL
Other descriptive name: sildenafil

Boehringer Ingelheim France

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;Italy;United Kingdom;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of

EUCTR2015-005131-40-CZ
(EUCTR)

20/03/2017

16/12/2016

A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease.

A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION.

Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

176

Phase 2

United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands

EUCTR2015-005131-40-HU
(EUCTR)

16/01/2017

01/12/2016

A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease.

Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

176

Phase 2

United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Hungary;Czech Republic;Canada;Belgium;South Africa;Netherlands;Germany

NCT02951429
(ClinicalTrials.gov)

December 31, 2016

28/10/2016

Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension

A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients With Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Group 3 Pulmonary Hypertension

Idiopathic Pulmonary Fibrosis

Drug: Pirfenidone;Drug: Placebo;Drug: Sildenafil

Hoffmann-La Roche

NULL

Completed

40 Years

80 Years

All

177

Phase 2

Belgium;Canada;Czechia;Egypt;Germany;Greece;Hungary;Israel;Italy;Netherlands;South Africa;Spain;Turkey;Czech Republic;United Arab Emirates

EUCTR2015-005131-40-BE
(EUCTR)

16/12/2016

20/10/2016

Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

176

Phase 2

United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2015-005131-40-DE
(EUCTR)

08/12/2016

25/10/2016

A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Addedto Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis andRisk of Pulmonary Hypertension due to the lung disease.

A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLEDSTUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTSWITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION.

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

176

Phase 2

United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands

EUCTR2015-005131-40-GR
(EUCTR)

06/12/2016

03/11/2016

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

176

Phase 2

United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Netherlands;Germany

EUCTR2015-005131-40-NL
(EUCTR)

02/12/2016

13/10/2016

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

176

Phase 2

United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Netherlands;Germany

EUCTR2015-005131-40-ES
(EUCTR)

20/10/2016

09/09/2016

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

176

Phase 2

United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands

EUCTR2015-002619-14-GB
(EUCTR)

01/08/2016

08/09/2016

Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment

INSTAGE(TM): A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM)

patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
MedDRA version: 19.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Boehringer Ingelheim Limited

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2015-002619-14-BE
(EUCTR)

25/07/2016

03/06/2016

Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment

INSTAGE (TM) : A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE (TM)

SCS Boehringer Ingelheim Comm. V

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of

EUCTR2015-002619-14-DE
(EUCTR)

21/07/2016

04/05/2016

Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment

patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Boehringer Ingelheim Pharma GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of

NCT02802345
(ClinicalTrials.gov)

June 30, 2016

14/6/2016

Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment

INSTAGE: A 24-week, Double-blind, Randomized, Parallel-group Study Evaluating the Efficacy and Safety of Oral Nintedanib Co-administered With Oral Sildenafil, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Advanced Lung Function Impairment

Idiopathic Pulmonary Fibrosis

Drug: Nintedanib;Drug: Placebo;Drug: Sildenafil

Boehringer Ingelheim

NULL

Completed

40 Years

N/A

All

274

Phase 3

United States;Australia;Belgium;Canada;France;Germany;India;Italy;Japan;Korea, Republic of;Mexico;Spain;United Kingdom

EUCTR2015-002619-14-ES
(EUCTR)

29/06/2016

17/05/2016

Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment

Boehringer Ingelheim España, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of

NCT01382368
(ClinicalTrials.gov)

September 2011

2/5/2011

Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients

Chronic Obstructive Pulmonary Disease;Idiopathic Pulmonary Fibrosis

Drug: Sildenafil

Rabin Medical Center

NULL

Enrolling by invitation

30 Years

90 Years

Both

Phase 4

Israel

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT00981747
(ClinicalTrials.gov)

September 2009

19/9/2009

Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis

A Clinical Treatment Trial Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis;Pulmonary Fibrosis

Drug: Sildenafil;Drug: Losartan;Drug: Sildenafil and Losartan;Drug: Placebo Oral Tablet

Alicia Gerke

Pulmonary Fibrosis Foundation

Terminated

18 Years

99 Years

All

Phase 2;Phase 3

United States

NCT00517933
(ClinicalTrials.gov)

August 2007

15/8/2007

Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis

Pulmonary Fibrosis;Hypertension, Pulmonary

Drug: Sildenafil Citrate;Other: Placebo

Duke University

National Heart, Lung, and Blood Institute (NHLBI);Pfizer

Completed

18 Years

N/A

All

180

Phase 3

United States

NCT00625079
(ClinicalTrials.gov)

February 2007

19/2/2008

Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil

Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot Study

Pulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis;Interstitial Lung Disease;Pulmonary Hypertension

Drug: sildenafil

University of California, Los Angeles

Pfizer

Withdrawn

N/A

All

Phase 4

United States

NCT00359736
(ClinicalTrials.gov)

July 2006

31/7/2006

Sildenafil Study to Treat Idiopathic Pulmonary Fibrosis

Vasodilator Therapy and Exercise Tolerance in IPF Patients

Alveolitis, Fibrosing;Fibrosis, Pulmonary;Hypertension, Pulmonary

Drug: sildenafil

VA Office of Research and Development

NULL

Completed

40 Years

85 Years

All

Phase 2

United States

NCT00352482
(ClinicalTrials.gov)

November 2004

13/7/2006

Sildenafil to Increase Exercise Capacity in Individuals With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension

Sildenafil Treatment in Patients With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - a Pilot Cross-over Study

Pulmonary Fibrosis;Hypertension, Pulmonary

Drug: Sildenafil (50 mg)

National Heart, Lung, and Blood Institute (NHLBI)

NULL

Completed

19 Years

N/A

Both

Phase 2

United States